Licensure For Pharmacists

Original Language Title: Approbationsordnung für Apotheker

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Pharmacist Approbationsordnung (AAppO)

Nontampery Table of Contents

AAppO

Date of Date: 19.07.1989

Full quote:

" Approbationsordnung für Apotheker vom 19. July 1989 (BGBl. 1489), as last amended by Article 1 of the Regulation of 2 June 2000. August 2013 (BGBl. I p. 3005) "

:Last modified by Art. 1 V v. 2.8.2013 I 3005

For details, see Notes

Footnote

(+ + + Text evidence from: 1.10.1989 + + +)
(+ + +)
for details on the basis of EinigVtr, see § 23 + + +)

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input formula

On the basis of § 5 of the federal pharmacist order of 5. June 1968 (BGBl. 601), paragraph 1 of which is Article 1 (2) of the Law of 19. June 1989 (BGBl. 1106), and paragraph 2 thereof, by Article 1 (2) (b) of the Law of 23. July 1988 (BGBl. 1077), as well as Section 14 (3) of the Federal Pharmacists ' Order, which is provided for by Article 23 of the Law of 25. June 1969 (BGBl. I p. 645):

First Section
The Pharmaceutical Training

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§ 1 outline of training

(1) The pharmaceutical training includes
1.
a study of pharmacy of four years at a university;
2.
a family of eight Weeks;
3.
a practical training of twelve months;
4.
The Pharmaceutical Review, which is to be deposited in three examination sections.
(2) The examination sections of the Pharmaceutical Review are filed:
1.
the first section after studying pharmacy of at least two years,
2.
the second section After passing the First Section of the Pharmaceutical Examination and a Study of Pharmacy of at least four years,
3.
the Third Section after the existence of the
the standard period of study within the meaning of Section 10 (2) of the Higher Education Framework Act is four years. Non-official table of contents

§ 2 University education

(1) The university education is to be used by the students, taking into account the requirements , and the changes in the professional world, provide the necessary knowledge, skills and methods in such a way as to enable them to carry out scientific work, to critically enact the scientific knowledge and to carry out the exercise of the Pharmacists ' professional skills are enabled.(2) The university education includes an education for the areas listed in Appendix 1 and an elective subject, which are in the form of lectures, seminars and practical courses with the specified number of rules and Certificates must be provided. Non-official table of contents

§ 3 Famulature

(1) The trainee with the pharmaceutical activities shall be due to the family according to § 1, paragraph 1, no. 2 shall be made familiar. It also aims to gain an insight into the organisation and operational procedures, as well as the legislation for pharmacies and the specialist language.(2) During the course-free periods of the course of study, the family is to be paid all day prior to the notification of the first section of the Pharmaceutical Examination under the direction of a pharmacist. At least four weeks of the Famulatur are to be paid in a public pharmacy that is not a two-gaded pharmacy; the rest of the time may also be available in
1.
a hospital or federal pharmacy counter,
2.
the pharmaceutical industry or
3.
of a drug investigation body or a comparable facility including the Bundeswehr
. The period referred to in the last sentence of the last sentence may also be used in comparable facilities in one of the other Member States of the European Union or in another State Party to the Agreement on the European Economic Area or in a The Contracting State to which Germany and the European Union have contractually granted an appropriate legal claim shall be made. A payment in sections of at least four weeks is permitted. The trainee receives a certificate according to the model of Appendix 7 on the family-run family.(3) Famulature is dispensed with for pharmacists 'assistants, pharmaceutical engineers, pharmaceutical assistants and pharmacists' assistants. Non-official table of contents

§ 4 Practical training

(1) The practical training referred to in § 1 (1) no. 3 shall be found after the existence of the second Section of the Pharmaceutical Review instead. It is divided into an education of
1.
six months in a public pharmacy that does not Two-gapotheke, and
2.
six months, optionally in
a)
a pharmacy according to number 1,
b)
a hospital or federal mortgage counter,
c)
of the pharmaceutical industry,
d)
a university institute or other suitable scientific institutions, including the Bundeswehr,
e)
of a drug investigation body or similar institution, including: to those of the Bundeswehr
Three months of training pursuant to sentence 2 (2) (b) may also be provided on the ward of a hospital or a Bundeswehr hospital.(2) During all-day practical training, the pharmaceutical knowledge acquired during the previous course of study is to be deepened, extended and practically applied. Training shall include, in particular, the development, production, testing, evaluation and delivery of medicinal products, the collection, evaluation and dissemination of information, in particular on the risk of medicinal products, and advice on medicinal products. The training also includes medical devices that are placed on the market in pharmacies. The training must be managed by a pharmacist who is a principal professional in the training centre, provided that it is carried out at a university institution, and that it includes a pharmacoscientific activity under the supervision of a Professors, university lecturers or private lecturers.(3) The trainee has to make available his/her work force on a regular basis and prepare himself for the third section of the Pharmaceutical Examination. It may only be used for activities which promote its training. The trainee receives a certificate according to the model of Appendix 5 on the practical training.(4) During practical training, the apprentier has to take part in accompanying educational events in which the areas listed in Appendix 8 are mediated. The competent authority shall carry out the accompanying teaching events or appoint one or more appropriate bodies to carry out such training events. The trainee shall receive a certificate according to the model of Appendix 6 on participation in the accompanying teaching events.(5) The training referred to in paragraph 1 shall be subject to interruptions up to the periods of holiday defined by the Federal Armed Services Agreement.

Second Section
General Examination Regulations

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§ 5 State Examination Office

(1) The examination sections provided for in this regulation will be submitted before the National law responsible (State Examination Office) is filed.(2) The examination sections shall be deposited in front of the State Examination Office of the country in which the examinee has studied pharmacy at the time of the notification for examination or has recently studied pharmacy. Repeat exams must be submitted before the State Examination Office, where the examination section has not been passed. Exceptions to the first and second sentences may be allowed for important reasons. The decision shall be taken by the State Examination Office where the authorisation is requested, in consultation with the State Examination Office, which is competent in accordance with sentence 1 or 2.(3) In the case of examination applicants, during which periods of a related study or of a pharmacy study or related studies operated outside the scope of this Regulation and, where applicable, those filed within the framework of such studies, Examinations according to § 22 can be credited, if a jurisdiction according to sentence 1 is not given, § 22 para. 5 applies accordingly. Non-official table of contents

§ 6 Notification of examination

(1) The State Examination Office decides on the admission to the individual examination sections.(2) The application for admission to a section of the examination must be made in writing in the form prescribed by the State Examination Office and must be submitted in writing for the first part of the pharmaceutical examination up to the 10th. January or up to 10. The Federal State Examination Office (Landesaudit) was granted in June. The application for admission to the second and third sections of the Pharmaceutical Examination must be received by the State Examination Office up to the date announced by the State Examination Office.(3) The application for admission to the first section of the Pharmaceutical Examination shall be attached to
1.
Birth certificate, in the case of married couples also the marriage certificate,
2.
proof of the university entrance qualification, in the case of certificates outside the scope of this 3.
The proof of the family nature (Annex 7), or in the cases of § 3 (3) of the Regulation, have been acquired by the competent authority
4.
The proof of a two-year pharmacy study,
5.
the certificates on the regular and successful participation in the events on the areas listed in Appendix 1 to letters A to D, according to the model of the Appendix 2.
6.
(omitted)
(4) To be attached to the application for admission to the second section of the Marketing Authorisation Examination style="font-weight:normal; font-style:normal; text-decoration:none; ">
1.
the testimony of the existence of the First Section of the Pharmaceutical Review (Asset 10),
2.
the evidence of a pharmacy study of at least four years,
3.
Certificates concerning the regular and successful participation in the events relating to the areas referred to in Appendix 1 to points E to I, according to the model of Appendix 2,
4.
the certificate of the compulsory optional subject specified in Appendix 1, letter K, according to the model of Appendix 3.
5.
(omitted)
(5) The application for admission to the third section of the Pharmaceutical Review is to be attached
1.
The testimonies on the existence of the First and Second Section of the Pharmaceutical Review (Asset 10),
2.
the proof of practical training (Appendix 5),
3.
the proof of the Participation in the accompanying educational events (Annex 6).
(6) Insofar as the evidence referred to in paragraph 3 (4) and (5) as well as the evidence referred to in paragraph 4 (2) to (4) cannot yet be annexed to the application, they shall be included in one of the following: National Audit Office to determine the period of time to be determined. If the applicant has not completed the practical training referred to in Article 4 (1) when reporting to the third section of the Marketing Authorisation Examination, he has to submit a provisional certificate from the person responsible for the training, from: which indicates that it will complete the training up to the expected date of the examination. The final certificate issued in accordance with the model of Appendix 5 shall be returned immediately upon receipt and must be submitted to the State Examination Office at the latest at the beginning of the third section of the Marketing Authorisation Examination.(7) If there is evidence that there is a reason in the applicant who would lead to the failure of the Approbation as a pharmacist due to a lack of one of the requirements of § 4 (1) sentence 1 no. 2 or 3 of the Federal Pharmacopoian order, the reason for this is that The State Examination Office shall require the submission of further documents, in particular medical certificates or a certificate of management. The special interests of disabled examinees must be taken into account in order to ensure their equal opportunities in carrying out the tests. Non-official table of contents

§ 7 Approval of the Admission

(1) Admission to a Examination Section is to fail if
1.
The exam candidate does not or does not have the right to do so before the date mentioned in § 6 para. 2 , or does not submit the prescribed evidence, unless it makes an important reason to do so credibly, the status of the examination procedure still permits the examination applicant to participate, and the omitted act no later than four weeks before the examination date,
2.
in the case of § 6 para. 6, the applicants do not submit the missing evidence on time,
3.
the examination section in question must not be repeated.
(2) The admission to a section of the examination must be refused if there is a reason for the failure of the examination section. Approbation as a pharmacist due to a lack of one of the requirements of § 4 para. 1 sentence 1 no. 2 or 3 of the federal pharmacist order would lead. Non-official table of contents

§ 8 Type of Review

(1) In the first section of the Pharmaceutical Review, it will be written, in the second and third parties Section of the Marketing Authorisation Examination oral examination.(2) By way of derogation from paragraph 1, the body responsible under national law may allow, instead of written examination, the knowledge and skills required in the first section of the pharmaceutical examination to be demonstrated in a different way (alternative examination procedures). (3) Admission as an alternative examination procedure requires that
1.
the reform target is described and shows what qualitative improvements are expected for the pharmaceutical training of this examination procedure,
2.
a special study order to be issued by the university,
3.
it is ensured that the in the first section of the Pharmaceutical Examination, the knowledge and skills to be verified in this examination procedure shall be examined in a manner equivalent to written examination,
4.
a proper accompanying and final evaluation of this review process is guaranteed,
5.
The minimum and maximum durations of this examination process are set and renewal applications are based on evaluation results,
6.
the access to a course of study with an examination procedure corresponding to the regulation in the first section of the pharmaceutical examination or to a study course with an alternative
7.
the requirements under which the university can terminate this examination procedure are designated
8.
regulated, as is the case with a transition to another course of study in pharmacy with regard to further studies, the calculation of study periods and study achievements and
9.
is set to meet the requirements described in Appendixes 1, 2, 12, and 13.
(4) sees the alternate Examination procedure that the first stage of the pharmaceutical examination must not be filed shall be submitted to the documents referred to in Article 6 (3) (1) to (4) in the notification of the second part of the Marketing Authorisation Examination; the temporal § 15 (5) does not apply in this case. A certificate shall be issued in accordance with the model of Appendix 10, which shall show separately the results of the verification of tests carried out in accordance with paragraph 3, point 3, and equivalent to the first section of the pharmaceutical examination. Non-official table of contents

§ 9 Evaluation of audit services

(1) The following grades are to be used for the assessment of the performance of the test item:
"very good" (1)= an outstanding performance,
" good "(2)= a performance that is much higher than average requirements
" satisfying " (3)= a performance that meets average requirements in every respect,
"sufficient" (4)= a performance that still meets the requirements, despite its defects
"not sufficient" (5)= a performance that no longer meets the requirements due to significant defects.
2) The note of an examination section is calculated from the average of the individual grades of the examination subjects.(3) For the evaluation of the pharmaceutical examination, account should be taken of the notes (numerical value referred to in paragraph 2 in conjunction with the first sentence of paragraph 4) of the first, second and third parts of the pharmaceutical examination to form an overall mark. The overall grade for the pharmaceutical test is determined as follows:
a)
The note (numerical value) for the The first section is multiplied by two, the note (number value) for the second section with three and the note (numerical value) for the third section with two.
b)
The The sum of the figures obtained in accordance with point (a) is divided by seven.
(4) The grades of the examination sections and the overall grade for the pharmaceutical examination are calculated up to the second place after the comma. The numerical value determined in this way shall be indicated in the certificates referred to in Annexes 10 and 11. The grades of the individual exam sections as well as the overall grade of the Pharmaceutical Review will be evaluated as follows:
very good " with a number value of up to 1.5,
"good"with a numeric value over 1.5 to 2.5,
"satisfying"with a numeric value over 2.5 to 3.5,
"sufficient"for a Numerical value over 3.5 to 4.0.
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§ 10 Written examinations

(1) In the written examination, the To answer questions asked in writing in the supervision of supervisory work. It shall indicate which of the answers provided by the questions he/she considers appropriate.(2) The examination questions must be based on the knowledge generally required for the pharmacist and enable reliable test results.(3) In the written examination, the same examination questions must be asked in each case for all examinees. In determining the examination questions, the State Examination Offices are to serve in accordance with an agreement between the countries of a body which has the task of establishing examination questions for the first stage of the pharmaceutical examination. When the examination questions and answers are drawn up, it is necessary to determine which response will be recognised as appropriate. The State Examination Offices may make public the items to which the examination questions relate.(4) The audit tasks shall be checked by the State Examination Offices prior to the determination of the result of the examination to determine whether they are manifestly flawed, as measured by the requirements of paragraph 2. The second and third sentences of paragraph 3 shall apply accordingly. If this verification reveals that individual examination tasks are manifestly flawed, they shall be deemed not to have been filed. The prescribed number of questions for the individual examinations (Section 17 (2)) is diminished accordingly. The assessment of the written examination referred to in paragraphs 5 and 6 shall be based on the reduced number of examination questions. The reduction in the number of examination questions must not be detrimental to the disadvantage of a test item.(5) A subject which has been checked in writing has been passed if the proportion of the questions correctly answered by the examinee is no more than 18 of the hundred below the average examination performance of the examinees of the respective examination date in the entire Federal territory or if the examinee has answered at least 50 of the hundred of the questions correctly.(6) The performance of the written examination shall be assessed as follows:
If the examinee has reached the minimum number of correctly answered questions required for the existence of the examination referred to in paragraph 5, the grade shall be
" very good ",if it is at least 75 from the hundred,
" good ", if it is at least 50, but less than 75 of the hundred,
" satisfying ",if it is at least 25, but less as 50 of the hundred,
"sufficient",if it is the minimum number, but less than 25 of the

of the , has answered correctly. If the examinee did not reach the minimum number of questions which were correctly answered for the passing of the examination, the grade "shall not be sufficient". (7) The result of the written examination is determined by the State Examination Office and shall be notified immediately to the examiner. The note for the examination section and the grades for each subject, the number of questions correctly answered by the examinee in the individual subjects, and the average examination performance are to be stated. Non-official table of contents

§ 11 Oral checks

(1) For the second and third parts of the pharmaceutical review, the State Examination Office appoints examination commissions. They consist of the Chairperson of the Examination Committee, other members and the members of the Board. For the Chairman and the other members, alternate members shall be appointed. The chairman is responsible for maintaining order.(2) For the second part of the Pharmaceutical Examination, an Examination Commission shall be formed at each university. The chairperson, the members and their deputies shall be professors or high school or private lecturers of the subjects covered by the examination, persons who shall at least determine the subjects to be determined by the examination or have an equivalent qualification. For examiners of the subject mentioned in § 18 (1) (v), others at the university in this subject can also be appointed independently lecturers. The examination in the individual subjects shall be carried out by the member of the examination board appointed for the subject in question in the presence of another member or a co-sitter. The chairman or his deputy may participate in the examinations in which he is not himself examiner, and ask for examination questions. In the case of repeat exams, the chairperson or a member of the examination board appointed by the examiner must be present in addition to the examiner, who may also ask for examination questions. The examiner decides on the evaluation of the examination achievements; the other members of the examination board who are present at the examination must be heard beforehand.(3) The Examination Committee for the Third Section of the Pharmaceutical Examination shall consist of the Chairperson and at least two, at most four other members. Members are professors and university or private lecturers of the university, as well as pharmacists who do not belong to the faculty of a university, to order. In addition, other suitable examiners can be ordered. The chairman is responsible for the audit; he is himself an auditor. It must ensure that the test specimens are interviewed in a suitable manner. The examination board shall be present throughout the examination. The examination committee shall take its decision with a majority of votes. In the event of a tie, the Chairman's vote shall indicate the rash.(4) The test specimens shall be tested individually or in groups of up to four persons.(5) The competent authority may send observers to the oral examinations. In the second section of the Pharmaceutical Review, the examiner may, in the third section of the Pharmaceutical Examination, the Chairperson of the Examination Board, be up to five persons who prepare for the same section of the Pharmaceutical Review as well as a representative of the competent pharmacists ' chamber, with the agreement of the examinee, to be present at the examinations. For important reasons or at the request of the test specimen as well as in the case of repeat tests, the public can be excluded. The persons referred to in sentence 2 shall not be present when the result of the examination is announced.(6) On the course of the examination of each test item, the examiner or a protocol guide appointed by the examiner or the chairman of the examination board, who may himself be a member of the examination board, shall have a record according to the model of the asset 9. The subject-matter of the examination, the evaluation of the overall performance and any serious irregularities must be considered. The minutes shall be signed by all the members of the Examination Committee present and the protocol guide.(7) The performance of an oral examination must be assessed in accordance with Section 9 (1). An oral examination has been passed if the examinee has received at least the grade "sufficient". The examination subject shall be notified to the examination subject for the individual examination subjects on the day of examination. The State Examination Office shall inform the examinee of the result in writing. Non-official table of contents

§ 12 Examination dates

(1) The State Examination Offices shall set the dates for the written examination in a uniform manner for the the scope of this Regulation. The oral exams of the second part of the Pharmaceutical Examination usually take place during the lecture-free period. The dates for the oral examinations of the Second and Third Section of the Pharmaceutical Examination are determined by the State Examination Office in consultation with the Examination Committee.(2) The repetition of a written examination shall be carried out within the framework of the next examination date referred to in the first sentence of paragraph 1. The date for the repetition of an oral examination or an oral examination section shall be determined by the State Examination Office in consultation with the Examination Committee. In order to participate in the repetition of a written examination, the examinee shall be the next examination date, for the repetition of an oral examination as a rule, to a date of examination, which shall be carried out within three months of the date of the unsuccessful examination. The Federal State Examination Office is responsible for loading the exam. § 13 shall apply.(3) The charge for testing shall be delivered to the examinee at the latest seven calendar days prior to the date of the examination. unofficial table of contents

§ 13 resignation and failure

(1) After admission to a review section, a resignation from an audit is only with the approval of the State Examination Office. The examinee must immediately inform the State Examination Office of the reasons for his resignation. If the State Examination Office approves the resignation of the entire examination section, of several technical examinations or of a technical examination, the examinations shall be deemed not to have been undertaken in that regard. The authorisation shall only be granted if there is an important reason. In the case of the illness, the State Examination Office may require the submission of a medical certificate or a medical certificate. If it does not approve the resignation of the entire examination section, of several subject examinations or of a technical examination, the examination shall be deemed to have not been passed.(2) Paragraph 1 shall apply mutafictily if the examinee fails to carry out an examination date, does not issue a supervisory work or does not deliver it on time, or if the examination breaks down or cancels.(3) § 12 para. 2 shall apply for the filing of the examination in a test section or examination subject which is not in force in accordance with paragraph 1 or paragraph 2 of this article. Non-official table of contents

§ 14 Disorder or deception

A test subject to a significant extent or to a significant extent to a test item is a fault of a test item. if he undertakes a deception, the State Examination Office, in the course of oral examinations in consultation with the Examination Commission, may declare the relevant examination or the entire examination section for "not passed". Non-official table of contents

§ 15 Passing and repeating exams

(1) A review section is passed if the exams are in all subjects. are passed. The pharmaceutical examination has been passed if the three examination sections have been passed.(2) A passed examination must not be repeated.(3) Any unpassed examination in one subject can be repeated twice. If the second repeat examination is not passed in one subject, then the entire examination section has not passed.(4) If a section of the examination has not been finally passed, the pharmaceutical examination as a whole has not been passed definitively. A repetition of the examination even after a renewed study of pharmacy is not permitted.(5) The evidence required for approval of the second stage of the Marketing Authorisation Examination may only be made before the first stage of the Marketing Authorisation Procedure has been established in the first section of the Marketing Authorisation for the first part of the examination. Semester.(6) If a technical examination of the third section of the Pharmaceutical Examination has not been passed, the Examination Commission shall decide whether and how long the examinee has to participate again in an education according to § 4. The period of participation shall not exceed three months. The State Examination Office shall inform the examinee in writing of the decision. Non-official table of contents

§ 16 testimonials and communications

(1) Following the existence of the first, second and third sections of the pharmaceutical In each case, the State Examination Office shall issue a certificate according to the model of Appendix 10, after the existence of the three sections of the Pharmaceutical Examination, a certificate according to the model of Appendix 11.(2) The State Examination Office shall inform the examinee and the other state examination offices if the pharmaceutical examination has not been definitively passed.

Third Section
The Pharmaceutical Audit

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§ 17 First section of the Pharmaceutical Review

(1) The first section of the Pharmaceutical testing extends to the following subjects:
I.
General, inorganic, and organic chemistry,
II.
basics of pharmaceutical biology and human biology,
III.
Basics of Physics, the Physical chemistry and drug formation,
IV.
Basics of pharmaceutical analytics.
(2) The tests can be found on four days in the order of paragraph 1. The examination shall take two and a half hours for the first two days and two hours in each of the following two days. The number of questions to be answered in the supervisory work and their distribution to the individual subjects is the result of Annex 12.(3) The questions must be placed on the test substance set out in Annex 13. Non-official table of contents

§ 18 Second section of the pharmaceutical review

(1) The second section of the Pharmaceutical Review extends to the following subjects:
I.
Pharmaceutical/Medical Chemistry,
II.
Pharmaceutical Biology,
III.
Pharmaceutical Technology/Biopharmaceuticals,
IV.
Pharmacology and Toxicology,
V.
Clinical Pharmacy.
(2) The reviews in the As a rule, individual subjects shall be deposited immediately one after the other, with interruptions up to a maximum of eight days. Each test shall take at least 20 minutes for a test specimen, not more than 40 minutes.(3) The questions shall be placed on the test material defined in Annex 14. Non-official table of contents

§ 19 Third section of the pharmaceutical review

(1) The third section of the Pharmaceutical Review extends to the following subjects:
I.
Pharmaceutical Practice,
II.
Special jurisditions for pharmacists.
(2) The check should take at least a half and a maximum of one hour for a test item.(3) The examination questions must be placed on the test substance specified in Appendix 15. The test shall determine whether the test item has the knowledge required to exercise the profession of pharmacist.

Fourth Section
The Approbation

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§ 20 Application for an Approbation

(1) The application for the application of the Approbation as a pharmacist is to be sent to the competent authority of the the country in which the applicant has passed the third section of the Marketing Authorisation Examination. The application must be attached to
1.
a short CV,
2.
the birth certificate, where married also the marriage certificate,
3.
an identity certificate,
4.
an official certificate that may not be issued earlier than one month before the template,
5.
a statement from the applicant about whether a judicial criminal case or prosecutor is pending against him
6.
a medical certificate that may not be older than a month from which the applicant is not unsuitable in terms of health to exercise the profession and
7.
the certificate of the existence of the pharmaceutical exam.
(2) As far as the evidence is not issued in the German language, they are additionally in a certified translation. The competent authority may request the presentation of further evidence, in particular on the authenticity of the documents submitted and on the activity to date. The second sentence does not apply to the pharmaceutical diplomas, certificates and other evidence of formal qualifications listed in the Appendix to § 4 (1a) sentence 1 of the Federal Pharmacist Order.(3) If the applicant has already exercised the profession of pharmacist in the country of origin, the competent authority of the competent authority of the Member State of origin may provide the competent authority of the competent authority of the Member State of origin with information on, for example, the applicant. (a) the imposition of penalties or other professional or criminal measures on the grounds of serious and precisely determined unlawful conduct or criminal acts which affect the exercise of the profession in the country of origin. If the competent authority responsible for issuing the Approbation as a pharmacist has knowledge in the case of the first sentence of the facts which have occurred outside the scope of the Federal Pharmacist Code and in respect of the conditions of § 4 The first sentence of the first sentence of paragraph 1 of the Federal Pharmacy Code may be relevant, it shall inform the competent body of the State of origin and ask them to review these facts and to ask the competent authority of the State of origin the result and the consequences which they may have in respect of the certificates and evidence it has issued, to be notified.(4) (omitted) (5) At the latest three months after the submission of the documents to be submitted by the applicant pursuant to paragraphs 1 and 2 as well as § 4 (6) of the Federal Pharmacist Order, the application pursuant to § 4 (1) of the Federal Pharmacists ' Order shall be submitted at the latest. decision. Within one month of receipt of the application, the competent authority shall confirm to the applicant in accordance with § 4 (1) to (3) of the Federal Pharmacist Order the receipt of the application and the receipt of the documents and shall inform him of the absence of documents. The competent authority shall, within one month of receipt of the application, confirm to the applicant or the applicant the receipt of the application and the receipt of the dossier and inform him or her of the absence of documents. Non-official table of contents

§ 21 Approbationsurkunde

The approbation certificate is issued according to the model of asset 16. It must be handed over to the applicant for receiving or receiving a certificate of delivery.

Fifth section
Supplementary provisions, permission, transitional and final provisions

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§ 22 Invoice of training times and examinations

(1) The body responsible under national law shall count on the training provided for in this Regulation, in so far as equivalence is given, in whole or in part, to
1.
periods of time within the scope of this Regulation
2.
periods of study of pharmacy or related studies carried out outside the scope of this Regulation. Studies,
3.
periods of practical training completed outside the scope of this Regulation on the training provided for in Section 4 (1) (2).
(2) Under the conditions laid down in paragraph 1, the State Examination Office shall recognise exams which have been filed in the course of studies in accordance with paragraphs 1 and 2 of paragraph 1. This shall not apply to the examination of the Third Section of the Pharmaceutical Examination.(3) In the case of recognition of an examination in the course of studies referred to in paragraph 1, point 1, the grade of the approved test shall be used in the formation of the note of the examination section concerned. In the case of recognition of an examination in the course of studies referred to in paragraph 1 (2), a grade of the examination section and an overall grade of the pharmacist examination shall not be formed. The offsetting of tests shall be noted, where appropriate, on the certificates of the examination sections and the certificate of the pharmacists ' examination in accordance with Annexes 10 and 11.(4) (omitted) (5) Invoice or recognition shall be made on request. The competent authority for the decisions referred to in paragraphs 1, 2 and 4 shall be the State Examination Office of the country in which the applicant for the study of pharmacy is registered or approved. In the case of students who have not yet obtained enrollment or admission to the pharmacy course at a university within the scope of this Regulation, the State Examination Office of the country in which the applicant is born shall be responsible. If this does not result in any jurisdiction, the State Examination Office of the State of Hessen is responsible. Non-official table of contents

§ 22a Permission pursuant to § 11 paragraph 1 of the federal pharmacy order

(1) The application for the grant of a permit to the The temporary exercise of the pharmacist's profession in accordance with § 11 (1) of the Federal Pharmacist Code shall be addressed to the competent authority of the country in accordance with Section 12 (3) of the Federal Pharmacotic Code. If the applicant for the first time requests the grant of the permit, he shall attach the following documents to the application:
1.
a proof of identity,
2.
a tabular list of completed training courses and the
3.
an officially certified copy of the certificate of completed training for the profession of pharmacist and, where appropriate, the certificate of professional experience acquired by the applicant,
4.
a declaration of where and in what way the applicant will exercise the profession of pharmacist in the country ,
5.
if available, the communication pursuant to § 4 (3) sentence 2 of the Federal Pharmacy Order and the minutes on the state proficiency test according to § 22d paragraph 5,
6.
the following documents:
a)
an official domestic certificate,
b)
the documents issued by the competent authorities of the The State of origin has been issued and evidence that the applicant has not found himself guilty of any conduct resulting from his unworthiness or unreliability in the pursuit of the profession of pharmacist, or,
c)
if in the home state the documents referred to in (b) are not issued, an affidavit or in the States where there is no affidavit, a a solemn declaration made by the person concerned in the country of origin or in the country before a competent judicial or administrative authority, or, where appropriate, in front of a notary or a duly authorised professional organisation, which shall be responsible for the certified statement certifying affirmative or solemn declaration has issued
7.
a medical certificate issued domesticly, from which: that the applicant is not unsuitable for the exercise of the profession in health terms; in so far as the applicant's place of residence is not within the country, a corresponding proof required in the country of origin may be required; or, where such proof is not required in the country of origin, a certificate issued by a competent authority of the State of origin,
8.
where available, evidence of the knowledge of the German language, which allows the competent authority to assess the extent to which the applicant is responsible for the The profession of pharmacist must have the necessary language skills.
The documents referred to in the second sentence of the second sentence of paragraph 6 and 7 may not be older than three months in the case of their submission. If the applicant requests the extension of the permit, he has the last permission granted, if the latter was issued by another authority, and an official domestic certificate and a domestically issued licence. shall be accompanied by a medical certificate which may not be older than three months when presented. Where the competent authorities have reasonable doubts as to the authenticity of the certificates and evidence of formal qualifications issued in the country of origin, they may, by the competent authorities of the home Member State, confirm the The authenticity of these certificates and evidence is required. Section 20 (2) and (3) shall apply accordingly.(2) The application shall be made in the short term, not later than three months after the submission of the documents to be submitted by the applicant, in accordance with paragraph 1. The competent authority shall, within one month of receipt of the application, confirm to the applicant the receipt of the application and the receipt of the dossier, and shall inform him of the absence of documents. In order to assess whether the documents submitted by the applicant in accordance with the second sentence of the second sentence of paragraph 1 prove that the training is completed in the country of origin, information from the Central Office for Foreign Education or from comparable facilities, the Authority shall also inform the applicant accordingly. In the cases of the third sentence, the expiry of the period referred to in the first sentence shall be inhibited until the reply to the authority of the Authority has been fulfilled. The same shall apply until confirmation of authenticity by the authority of the home Member State referred to in paragraph 1, sentence 5.The competent authority shall take into account the applicant's level of training, including proven relevant professional experience, in deciding on the granting of the permit, and shall, on this basis, examine his professional qualifications. Suitability for the intended pharmaceutical activity. To the extent that the applicant has already submitted an application for the grant of the Approbation, the competent authority shall draw up the findings of the certificate pursuant to Article 4 (2) sentence 8 of the Federal Pharmacist Order and, where available, the minutes of the state proficiency test in accordance with § 22d (5). An appropriation procedure which has already been granted or not yet completed in accordance with § 4 (3) of the Federal Pharmacist Code with a recognition shall not preclude the granting of permission.(4) The competent authority shall provide for the authorisation of the restrictions and secondary provisions necessary to ensure that the applicant's knowledge of the German language is taken into account in the light of the applicant ' s training status as assessed in accordance with paragraph 3. and its fitness for health risks to public health. If the danger to public health cannot be ruled out by restrictions and by-laws, permission to fail is to be refused. Permission must also be refused if the requirements of § 4 (1) (2) of the Federal Pharmacist Code are not available.(5) The permit may be limited to less than two years on the occasion of its initial grant only if, on a case-by-case basis, the restrictions and secondary provisions provided for by the permit or the professional activity intended by the applicant requiring this.(6) In so far as the validity of the permit is restricted to a country and the activity requires an operation in more than one country, the competent authority shall provide the permit with the indication in which other countries the permit applies.(7) The permit for the temporary exercise of the profession of pharmacist shall be issued in accordance with the model of Appendix 17 to this Regulation. Non-official table of contents

§ 22b Permission pursuant to Section 11 (1a) of the Federal Pharmacists ' Order.

(1) The application for temporary exercise the pharmacist's profession in accordance with § 11 (1a) of the Federal Pharmacist Code shall be addressed to the competent authority of the country in accordance with Section 12 (3) of the Federal Pharmacotic Code. If the applicant for the first time requests the grant of the permit, he shall attach the following documents to the application:
1.
the documents referred to in § 4 (6), first sentence, points 1, 1a, 2 and 3 to 7 of the federal pharmacist order, and
2.
a statement where and in what way the applicant wants to practice the pharmacy profession in Germany and to what extent a particular interest in the granting of the permit .
The evidence in accordance with Section 4 (6), first sentence, number 3 and 4 of the Federal Pharmacist Order may not be older than three months on presentation. If the applicant requests the extension of the licence, he has the last permission granted, if the latter has been issued by another authority, and the documents in accordance with § 4 (6) sentence 1 (3) and (4) of the federal pharmacist order, which may not be more than three months in the case of their submission. Where the competent authorities have reasonable doubts as to the authenticity of the certificates and evidence of formal qualifications issued in the country of origin, they may, by the competent authorities of the home Member State, confirm the authenticity and confirmation that the applicant complies with the minimum training requirements laid down in Article 44 of Directive 2005 /36/EC of the European Parliament and of the Council of 7 November 2005 on the application of the European Parliament and of the Council to the European Parliament and of the Council on the On the recognition of professional qualifications (OJ L 327, 28.12.2005, p. 22, L 271 of 16.10.2007, p. 18), as last amended by Regulation (EU) No 623/2012 (OJ L 327, 22.12.2012, p. 9), as amended by Regulation (EU) No 1891/12 (OJ L 180, 12.7.2012, p. Section 20 (2) and (3) shall apply accordingly.(2) A particular interest within the meaning of Article 11 (1a) of the Federal Pharmacist Code shall be in particular if the applicant is
1.
the requirements of § 4 (1) or (2) of the federal pharmacist order are fulfilled and § 11a of the federal pharmacist order cannot be applied or
2.
the pharmaceutical activity sought according to the second sentence of the second sentence of the second sentence of paragraph 1 may be carried out even though it fulfils the conditions laid down in Article 4 (1), first sentence, point 3 or point 5 of the Federal Pharmacy Regulations are not fulfilled.
(3) The applicant does not satisfy the condition of § 4 (1) sentence 1 (4) of the Federal Pharmacist Order and the applicant does not fall under § 4 (1a) or § 4 (1d) of the German Federal Pharmacist Code. Federal pharmacist order, § 22a (3) sentence 1 shall apply accordingly.(4) The competent authority shall provide permission with the restrictions and secondary provisions necessary to ensure that the applicant's knowledge of the German language is taken into account, taking into account the level of knowledge of the applicant as assessed in accordance with paragraph 3 of this article. of his health is to be excluded from public health risks. The provisions of Articles 22a (2), 4 (2) and (3), (5) to (7) shall apply. Non-official table of contents

§ 22c aptitude test in accordance with § 4 paragraph 2 sentence 7 of the federal pharmacy order

(1) The aptitude test in accordance with § 4 paragraph 2 sentence 7 of the federal pharmacy order refers to the subjects in which the competent authority has established substantial differences in accordance with § 4, paragraph 2, sentence 8 of the federal pharmacist order. In the aptitude test, the applicant has to prove that he/she has knowledge and skills in these subjects, including in the pharmacy course, which are necessary for the exercise of the pharmacist's profession.(2) The aptitude test is an oral examination which takes place in one day. The examination is usually carried out as an individual examination. To the extent that the subjects to be tested permit, up to four applicants can be examined simultaneously. The duration of the test shall be based on the extent of the significant differences observed. It shall take at least 30 minutes for each applicant, not more than 60 minutes.(3) Countries may use the regular examination dates of the state examinations in accordance with § 12 (1) sentence 3 for the performance of the examinations. The competent authority of the country in accordance with Section 12 (2) of the Federal Pharmacist Order shall provide the applicant with the charge for the aptitude test not later than seven days before the date of the examination. § 13 shall apply accordingly.(4) The aptitude test is filed in the form of a state examination before a state examination commission in German. The Examination Committee is appointed by the competent authority of the country according to § 12 (2) of the Federal Pharmacist Order. The Examination Board shall consist of the Chairperson and at least two, at most four other members. For the Chairman and the other members, alternate members shall be appointed. As chairperson, other members and deputiors, professors or other teachers of the subjects who are the subject of the examination shall be appointed. Instead, the members of the examination board can also order a pharmacist who is not a member of a university's teaching body. The Chairman of the Examination Commission is in charge of the examination and must also consider itself. Articles 11 (3), 5, first sentence, and paragraph 6, as well as section 14, shall apply accordingly.(5) The aptitude test shall be completed successfully if the examination board evaluates the performance in the subjects mentioned in paragraph 1 as passed. The existence of the test requires at least that the performance, in spite of its defects, still meets the requirements. Section 11 (3) shall apply accordingly.(6) The aptitude test is to be offered at least twice a year. It can be repeated twice in each compartment. A record to be signed by all the members of the Examination Commission shall be drawn up in accordance with the model of Appendix 18 to this Regulation from which the subject-matter of the examination, the existence or the existence or the following shall be submitted to each applicant. Failure to pass the test, the reasons for this, and the serious irregularities that have been found. The Chairperson of the Examination Commission shall forward the minutes of the competent authority of the country in accordance with Section 12 (2) of the Federal Pharmacists ' Order. Non-official table of contents

§ 22d Proficiency test in accordance with § 4 (3) sentence 3 of the federal pharmacy order

(1) The proficiency test refers to the Subjects Pharmaceutical practice and special areas of law for pharmacists as well as on one of the subjects in which the competent authority has established substantial differences in accordance with § 4 (2) sentence 8 of the federal pharmacist order and that of the competent authority according to § 12 (3) The competent authority of the country shall be established by the federal pharmacist order. In the examination, the applicant has to show that he has knowledge and skills, including in the pharmacy course, which are necessary for the exercise of the pharmacist's profession.(2) The proficiency test is an oral examination which takes place in one day. The examination is usually carried out as an individual examination. To the extent that the subjects to be tested permit, up to four applicants can be examined simultaneously. The duration of the test shall be based on the extent of the significant differences observed. It shall take at least 30 minutes for each applicant, not more than 60 minutes.(3) Countries may use the regular examination dates of the state examinations in accordance with § 12 (1) sentence 3 for the performance of the examinations. The competent authority of the country in accordance with Section 12 (2) of the Federal Pharmacist Order shall provide the applicant with the charge for the examination of knowledge not later than seven days before the date of the examination. § 13 shall apply accordingly.(4) The proficiency examination is filed in the form of a state examination before a state examination board in German. The Examination Committee is appointed by the competent authority of the country according to § 12 (3) of the Federal Pharmacist Order. The Examination Board shall consist of the Chairperson and at least two, at most four other members. For the Chairman and the other members, alternate members shall be appointed. As chairperson, other members and deputiors, professors or other teachers of the subjects who are the subject of the examination shall be appointed. Instead, the members of the examination board can also order a pharmacist who is not a member of a university's teaching body. The Chairman of the Examination Commission is in charge of the examination and has to examine it himself. Articles 11 (3), 5, first sentence, and paragraph 6, as well as section 14, shall apply accordingly.(5) The proficiency test shall be completed successfully if the examination board, in an overall view, evaluates the performance in the subjects referred to in paragraph 1 as passed. The existence of the test requires at least that the performance, in spite of its defects, still meets the requirements. Section 11 (3) shall apply accordingly.(6) The proficiency test shall be offered at least twice a year. It can be repeated twice. A record to be signed by all the members of the Examination Commission shall be drawn up in accordance with the model of Appendix 19 to this Regulation from which the subject-matter of the examination, the existence or the existence or the following shall be submitted to each applicant. Failure to pass the test, the reasons for this, and the serious irregularities that have been found. The Chairperson of the Examination Commission shall forward the minutes of the competent authority of the country in accordance with Section 12 (2) of the Federal Pharmacists ' Order. Non-official table of contents

§ 22e communication pursuant to § 4 (2) sentence 8 and paragraph 3 sentence 2 of the federal pharmacy order

The communication pursuant to § 4 (2) Sentence 8 and paragraph 3, second sentence, of the Federal Pharmacy Code shall contain the following information:
1.
the level of the Germany required qualification and level of qualification submitted by the applicants in accordance with the classification in Article 11 of Directive 2005 /36/EC, as amended,
2.
the subjects where significant differences have been detected
3.
a content explanation of the the main differences, as well as the reasons why they result in the applicant not having sufficient knowledge and skills required in Germany to exercise the profession of pharmacist, and
4.
justification as to why the main differences cannot be compensated by the knowledge and skills of the applicant in the context of his professional practice as a pharmacist
Non-official table of contents

§ 23 Transitional rules

(1) Persons who are studying pharmacy before the 1. The first section of the Marketing Authorisation Examination for a period prior to 1 October 2001 has been submitted to the Commission. In accordance with the provisions of this Regulation, the examination shall be carried out in accordance with the provisions of this Regulation in the period up to 30 July 2004. The text was adopted in September 2001. If you have this examination section after the 30. They shall continue to study in accordance with the provisions of this Regulation in the period after 30 September 2003. The text was adopted in September 2001.(2) Persons who are studying pharmacy before 1. The European Parliament and the Member States of the European Union and the United States of the European Union have submitted an application for authorisation to the second section of the Pharmaceutical Review for In accordance with the provisions of this Regulation, the examination shall be carried out in accordance with the provisions of this Regulation in the period up to 30 January 2006. (3) Persons who are studying pharmacy before 1 January 2007. Prior to the date of application of the Marketing Authorisation, the application for authorisation to the third section of the Marketing Authorisation Examination for a period before 1 October 2001 In accordance with the provisions of this Regulation, the examination shall be carried out in accordance with the provisions of this Regulation in the period up to 30 July 2007. (4) In the case of admission to the First or Second Section of the Pharmaceutical Examination, the prescribed evidence is in § 6 (3) (5) and (6) and (4) (3) and (4) of this Regulation in the up to 30 years of age. Article 6 (3) (5) and (4) (3) of this Regulation, in accordance with the provisions of Article 6 (3) (5) and (4) (3) of this Regulation shall be deemed to be equivalent to the version in force in September 2001.(5) repeat tests after an unpassed test, which shall be carried out in accordance with the provisions of this Regulation in the period up to 30 years. In the first section of the Marketing Authorisation Procedure, the first section of the Marketing Authorisation Procedure is up to 31 September 2001. 1 December 2005, in the second section of the Pharmaceutical Review, up to 31 December 2005. December 2006, and in the third section of the Marketing Authorisation Examination, up to 30 December 2006. This Regulation shall apply in accordance with the provisions of this Regulation in accordance with the provisions of this Regulation, which shall apply after 30 June The Commission shall also apply for such repeat tests as amended in September 2001.(6) The State Examination Office may apply for a prior to the 1st By way of derogation from Section 11 (2) sentence 3, the examination of the subject referred to in § 18 (1) (v) shall appoint another member of the Examination Board for the Second Section of the Pharmaceutical Examination. unofficial table of contents

§ 24

(omitted) unofficial Table of contents

§ 25 Entry into force of the Regulation and repeal provisions

This Regulation shall enter into force on 1 January 2008. October 1989, in force. Non-official table of contents

Final formula

The Federal Council has agreed.

The Federal Minister for Youth, Family, Women and Health Non-official table of contents

Appendix 1 (to § 2 para. 2)
fabric areas of the Studies of Pharmacy

Fundstelle des Originaltextes: BGBl. I 2000, 1716-1718 It is possible to shift lessons between the various areas of the fabric in the range of up to 42 hours per area. The total amount of practical exercises and seminars, including lectures with exercises or with seminars, may not be affected by this. In addition to the certificates specified for the areas A to I, the body responsible under national law may require a total of up to four additional certificates.
In the practical exercises, 20 percent practical seminars are included in each case. Material area A
General chemistry of drugs, excipients and pollutants
Lectures, seminars and practical exercises with events to:
Chemistry for pharmacists
Stereochemistry
Chemical nomenclature
General and analytical chemistry of the inorganic drugs, excipients and pollutants (including pharmacopoeial methods)
Chemistry including the analysis of the organic drugs, excipients and pollutants
Toxicology of the Excipients and pollutants
Total amount: 462 lessons with a share of 336 lessons practical exercises and 56 lessons seminars
Three certificates of successful and regular attendance Material Area B
Pharmaceutical Analysis
Lectures, seminars and practical exercises with events:
Pharmaceutical/Medical Chemistry
Quantitative determination of medical, auxiliary and harmful substances (including
Introduction to instrumental analytics
instrumental analytics
Total: 392 hours of teaching with a share of 308 lessons practical exercises
Two certificates of success and regular participation in the area C
Scientific basics, mathematics and drug formation
Lectures, seminars and practical exercises with events:
Physics for pharmacists
Basics of physical education Chemistry
Physical exercises for pharmacists
Physical-chemical exercises for pharmacists
Mathematical and statistical methods for pharmacists
Basics of drug form teaching
Pharmaceutical form teaching
Pharmaceutical and medical terminology
History of the natural sciences with special consideration of pharmacy
Total amount: 280 lessons with a share of 140 lessons practical exercises and 14 lessons Seminars
Three certificates of successful and regular participation Material Area D
Fundamentals of Biology and Human Biology
Lectures, seminars and practical exercises with events:
General Biology for Pharmaceuticals
Systematic classification and physiology of pathogenic and drug-producing organisms
Pharmaceutical Biology I (Investigations of Substance Producing Organisms)
Medicinal Plant Excursions, Exercises
Microbiology
Pharmaceutical Biology II (planting drugs)
Cytological and histological fundamentals of biology
Basics of anatomy and physiology
Course of physiology
Basics of the Biochemistry
Basic principles of nutrition
Total: 392 hours of teaching with a share of 210 lessons practical exercises
Four certificates of successful and regular participation Material area E
Biochemistry and Pathobiochemistry
Lectures, seminars and practical exercises with events:
Biochemistry and Molecular Biology
Fundamentals of Clinical Chemistry and Pathobiochemistry
Biochemical investigation methods Including Clinical Chemistry
Pathophysiology/Pathobiochemistry
Total: 196 lessons with a proportion of 98 lessons practical exercises
A certificate of successful and regular participation Material area F
Pharmaceutical technology and biopharmaceuticals
lectures, seminars and practical exercises with events on:
Pharmaceutical technology including medical devices
Quality assurance in manufacturing and Testing of medicinal products
Biopharmaceutical including pharmacokinetic pharmacokinetics
Total: 364 teaching hours with a share of 196 hours of teaching practical exercises and 42 classes of seminars
Two Certificates of successful and regular participation Materials area G
Biogenic drugs
Lectures, seminars and practical exercises with events:
Pharmaceutical Biology; Medicinal plants, biogenic drugs, Biotechnology
Biogenic medicines (phytopharmaceuticals, antibiotics, genetically engineered products)
Pharmaceutical Biology III (Biological and phytochemical studies)
Immunology, vaccines and sera
Total: 238 lessons with a share of 84 hours of teaching practical exercises and 42 classes of seminars
A certificate of successful and regular participation in the field of matter H
Medical chemistry and Medical analysis
Lectures, seminars and practical exercises with events:
Pharmaceutical/Medical Chemistry
Drug analysis (Drug Monitoring, toxicological and environmental studies)
Drug analysis with special consideration of the pharmacopoeia (quality control and safety of medicinal products) and the corresponding standards for medical devices
Total volume: 420 hours of teaching with a share of 280 Teaching hours Practical exercises
Two certificates of successful and regular participation Material Area I
Pharmacology and Clinical Pharmacy
Lectures, seminars and practical exercises with events:
Pharmacology and toxicology
Clinical Pharmacy
Disease of Disease
Pharmacotherapy
Pharmacologic Toxicological Demonstration Course
Pharmacoepidemiology and pharmacoeconomic
Special jurisditions for pharmacists
Total: 406 lessons with 112 lessons practical exercises and 98 hours of seminars
Three certificates of successful and regular participation fabric area K
elective subject
Seminars and practical exercises in a compulsory elective subject of the pharmaceutical sciences
Total: 112 lessons
A certificate of successful and regular attendance; seminar events Block K takes place in the form of main seminars. Non-tampering table of contents

Appendix 2 (to § 6 para. 3 no.5 and para. 4 no. 3)
certificate

(site of the original text: BGBl. I 2000, 1719)
on participation in the event .............................
of the fabric area .............................................................
The students of the pharmacy .............................................
has in ................................ from ...........................................
to ........................................................... participating in the above event
regularly and successfully.

Siegel .........., the .......................

.......................................
(Signature of Responsible
Professors/Lecturers)
unofficial table of contents

Appendix 3 (to § 6 para. 4 no. 4)
certificate

(site of the original text: BGBl. I 2000, 1719)
on participation in the event .............................
of the elective subject .........................................................
The students of the pharmacy .............................................................
has in ................................ from ...........................................
to ........................................................... participating in the above event
regularly and successfully.

Siegel .........., the .......................

.......................................
(Signature of Responsible
Professors/Lecturers)
unofficial table of contents

asset 4

(omitted) unofficial table of contents

Appendix 5 (Section 4 (3) sentence 3, § 6 (5) No. 2 and (6) sentence 3)
Certificate of practical training

(site of the original text: BGBl. I 1989, 1500)
Herr/Frau .......................... is in the time of the ...........
to ..................... in accordance with § 4 of the Approbationsordnung für Apotheker
(Approbationsordnung für Apotheker
).
He/she has worked all day in this period and has carried out the activities listed in § 4 paragraph 2
. The training
is from ............................................................
to ......................... *)

................, the ...........
seal or stamp
............................................................
(name of the training center)

.....................................
(signature of the training
Responsible)
----------
*) Delete as appropriate.
Non-official table of contents

Appendix 6 (to § 4 para. 4 sentence 3 and § 6 para. 5 no. 3)

certificate of participation in the accompanying Educational events according to § 4 paragraph 4 of the Approbationsordnung für Apotheker

(Fundstelle des Originaltextes: BGBl. I 1989, 1500)
Herr/Frau ..............................................................
has to do with the ... Accompanying educational events carried out in ..............

carried out.

................, the ...............
Seal/stamp
.....................................
(Signature)
unofficial Table of contents

Appendix 7 (to § 3 para. 2 sentence 4 and § 6 para. 3 no. 3)

certificate of activity as Famulus

(reference of the original text: BGBl. I 1989, 1501)
Herr/Frau ..............................................................
is in the time of ..................... to ..........................
pursuant to § 3 of the Approbationsordnung für Apotheker in the below designated
facility under my supervision and management acted as Famulus.

He/She has been collaborating all day in this time. The training is
from the ....................................................................
to ......................... has been interrupted/not interrupted. *)

..............................................................


.............................................................
(Signature of responsible
pharmacist)
--------
*) Delete as appropriate.
Non-official table of contents

Appendix 8 (to § 4 para. 4 sentence 1)
fabric areas that are taught during practical training

Source of the original text: BGBl. I 2000, 1720 Basic principles of formulation and defect, including the assessment of manufacturing requirements and procedures; Development, authorisation and manufacture of finished pharmaceuticals;
Planning, monitoring and disposition of the goods purchasing; technical procedures and storage problems; influence on the shelf life of medicinal products and medical devices placed on the market in pharmacies, by transport and storage;
procurement, evaluation, Evaluation and dissemination of information on medicinal products and medical devices, including safety aspects;
Information and advice to patients, doctors and members of other health care professionals on medicinal products and medical devices, which are placed on the market in pharmacies, in particular on the proper storage, use, incompatibilities and interactions, and the risks of permanent smoking and abuse of medicinal products;
communication techniques for the treatment of healthy patients, patients and their relatives, physicians and other health professionals;
aspects of quality assurance and quality control;
Applied pharmacotherapy; drug selection in self-medication; special treatment guidelines; limits of self-medication; interpretation of medical, dental and veterinary prescriptions and their terminology; pharmaceutical support; pharmacovigilant services;
blood and blood products;
Hospital hygiene;
Economic aspects of the use of medicines and medical devices;
Comparative assessment of products for infant and child nutrition; comparative assessment of nutritional measures including dietetic foods and dietary supplements; comparative evaluation of enteral and parenteral nutrition products;
Comparative assessment of products and articles for body care, of Medical products and pesticides;
Special features of veterinary medicinal products;
Special aspects of health promotion;
Accident prevention in pharmacy and in pharmaceutical products Operations including appropriate handling of hazardous substances, cytostatics, radiopharmaceuticals and radiopharmaceuticals; general measures in the event of accidents and poisoning (first aid);
operating economy for pharmacists, taking into account trade law, tax law and commercial accounting;
tasks and fields of activity of the pharmacist;
General legal round, professional law; legislation for pharmacy operations, marketing of medicinal products, Drugs, medical devices, dietetic foods, body care products, hazardous substances and plant protection products; medicinal products;
Special features of the national and international medicines market;
Organization of health administration at federal, state and local level as well as at the international level;
Pharmaceutical organizations and institutions;
Introduction to social legislation and social security. Non-official table of contents

Appendix 9 (to § 11 para. 6 sentence 1)
Niederschrift on the oral examination in the Second/Third *) Section of the Pharmaceutical examination in the subject .......................

(Fundstelle des Originaltextes: BGBl. I 1989, 1503;
bzexcl. of the individual amendments, cf. Footnote)
Herr/Frau ............................, born on .....................
in ................, is on ............ in ............
Subject of the review .........................................................
........................................................................

Notices + +)
........................................................................
........................................................................
He/She has passed the oral exam with the Note ........................
passed. *)

..............................

.............................
..............................
(Signature of the Chairman of the
................................ Audit Commission + + +))
(Signature (s) of the
Reviewer (s) *))

................................
(Signature of the Seat Seat) (Log Guide Signature)
--------
*)
Delete non-true.
+ +)
Here is also to be noted, if and if applicable, the number of repeat tests it is or, if necessary, the reasons for which the exam has not been passed
+ + +)
This applies to the Third Examination Section and to the case that the Chairman participates in an audit of the Second Examination Section
Non-official table of contents

Appendix 10 (to § 6 para. 4 no. 1, para. 5 no. 1, § 9 para. 4 sentence 2, § 16 para. 1 first half sentence and § 22 para. 3 sentence 3)

(Fundstelle des Originaltextes: BGBl. I 1989, 1504)
issuing authority
in ................................



above the first/second/third *) section of
pharmacist review

Mr./Mrs. ..........................., born on .......................
in ..................., has been on the ............... in ............... the
First/Second/Third *) Section of the Pharmaceutical Review after
of the Approbationsordnung für Apotheker mit der Note .........................
(..............)


Number Value

........................
Siegel
of the issuing authority
.............................
(Signature)

--------
*) Delete as appropriate.
Non-official table of contents

Appendix 11 (to § 9 para. 4 sentence 2, § 16 para. 1 second half sentence and § 22 para. 3 sentence 3)

(site of the Original text: BGBl. I 1989, 1504)
issuing authority
in .................................



on the pharmaceutical test

Mr./wife .........................., born on the .......................
in ....................,

has a Pharmaceutical Review

with a full note of ........... (..............) passed.
Number value

...................., the ............
seal
of the issuing authority
.....................................
(signature)
unofficial table of contents

asset 12 (for § 17 paragraph 2 sentence 3)
Number and distribution of examination questions in the individual subjects of the First Examination Section

Fundstelle des Originaltextes: BGBl. I 2000, 1721
I.General, inorganic and organic chemistry100 Questions
II.Basic principles of pharmaceutical biology and human biology100 Questions
III.Basics of Physics, Physical Chemistry and Drug Formation80 Questions
IV.basics of pharmaceutical analytics80 questions
Non-official table of contents

Annex 13 (to § 17 para. 3)
Auditing substance of the first section of the pharmacist review

Original text: BGBl. I 2000, 1721
General, inorganic and organic chemistry concepts and laws of chemistry; atomic structure and periodic table of elements; chemical bonding, intermolecular binding forces, Solutions and heterogeneous systems; Thermodynamics of chemical reactions and reaction kinetics; chemical equilibrium; acid/base and redox systems; stoichiometry of chemical reactions; occurrence, extraction, properties and reactivity of elements the periodic table and its compounds as well as their production; general chemistry of the medicinal products, excipients and pollutants; summary formulae and geometry of important compounds; nomenclature; binding species and their theoretical bases; Reaction equations and mechanisms; fundamentals of stereochemistry; chemistry of functional groups and classes of substances and their production and properties; sum, structure and stereotypes; properties and reactivity of synthetics and Natural materials; Chemical fundamentals of synthetic polymers and biopolymers; Nomenclature.
II.
Basic principles of pharmaceutical biology and human biology fundamentals Cytology and Histology; Basic principles and molecular principles of metabolism and genetics; Characteristics, systematic classification and physiology of plants and microorganisms, with particular emphasis on pharmaceutically and medically important organisms; vein; fundamentals of anatomy and morphology of plants; ecological basic concepts; drug and microbiological basic concepts and techniques; important medicinal and poisonous plants; common plants Drugs; macroscopic and microscopic structure of the human body, its organs and tissues; function of organs and organ systems, including regulation mechanisms and cell biological aspects; basic principles of the immune system; Reproductive organs and their function, pregnancy; composition and scope of normal diet.
III.
Basics of physics, physical chemistry and the Basic principles of the mechanics of solid bodies, liquids and gases; states of aggregation and their changes; phase systems; boundary surface phenomena; fundamentals of thermodynamics and kinetics; kinetics the diffusion and distribution; fundamentals of electricity theory including electrochemistry; fundamentals of optics, vibration and wave theory; structure and properties of atoms and molecules; fundamentals of radioactivity and isotope application; Physical fundamentals of measurement methods, taking into account the requirements of pharmacy; general requirements for the manufacture of pharmaceuticals; basic operations; medicinal products for prescription; homeopathic preparations.
IV.
Basics of the pharmaceutical analytic The basic methods used in the pharmaceutical analysis, the basis, the working methods and the application of classical qualitative and quantitative methods for the analysis of drugs, excipients and pollutants (cations, anions and neutral substances) including the pharmacopoeia method; analysis of functional groups of organic compounds; instrument pharmaceutical Analytical methods including trace analytical methods: fundamentals, working methods and applications of electrochemical, thermoanalytical, radiochemical, chromatographic, optical and spectroscopic methods for qualitative analysis (Identification and structure analysis) and quantitative analysis; validation of analytical methods; quality assurance.
Non-official Table of contents

Appendix 14 (to § 18 para. 3)
Examination material of the second section of the Pharmaceutical Review

site of the original text: BGBl. I 2000, 1722-1723
I.
Pharmaceutical/Medical Chemistry Structure, Stereochemistry, Common Representation or Extraction, Development (in particular rational drug development), Properties, Stability and analytics (identity, purity, content) of synthetic, partial-synthetic and natural active substances, narcotics, drugs, excipients and pollutants, as well as biocides and other xenobiotics; radiopharmaceuticals, synthesis and Quality control of sterically uniform optically active medicinal substances; bioreactivity and biotransformation of the active substances and xenobiotics; qualitative and quantitative relationships between structure and pharmacokinetic and pharmacodynamic Properties of the active substances, including stereochemical influences; chemical, physical-chemical, physical, radiochemical and biochemical methods of pharmacopoeias and the corresponding harmonised standards for medical devices, structure and function of important reagents; other physical, physical-chemical, chemical, radiochemical and biochemical methods for the investigation of substances used in the manufacture of medicinal products; application and validation of Methods for the quality control of the active substances and adjuvants; quality assurance measures in the analytical laboratory; chemical toxicology and handling of hazardous substances and other active substances; environmental analysis (water, soil, air); fundamentals of biochemistry (including pharmaceutical and chemical aspects of gene and biotechnology) and physiological, clinical and ecological chemistry; methods for the study of bodily fluids and interpretation of results; medicinal products; and Metabolic analysis, including in biological materials; pharmaceutically-chemical aspects of sera, vaccines and immunology; pharmaceutical-chemical investigations of pre-processed pharmaceutical products, such as separation and isolation of active substances and auxiliary substances , as well as their analysis; pharmaceutically-chemical aspects of the main, secondary and interactions and incompatibilities of finished pharmaceuticals; nomenclature and terminology of active substances and excipients, including stereochemical Aspects;
II.
Pharmaceutical Biological Incendiary Plants, Drugs and Phytopharmaceuticals; their extraction, ingredients, effect, therapeutic application and their pharmaceutical and clinical evaluation; detection, purity and quality testing of drugs; analytical methods for the investigation and standardisation of plant starting materials and ready-to-use preparations; isolation procedures of Natural substances; Enusive antibiotics and biogenic cytostatics; their production, mechanisms of action and therapeutic use; mechanisms of resistance development; Basic principles of biosynthesis of plant and microbial natural substances; Biochemistry and clinical chemistry; fundamentals of immunology; use of immunological and enzymatic methods in analysis and diagnostics; production, testing and use of vaccines, immunoglobulins and immunoglobulins; blood products; molecular biological Working techniques, genetic engineering methods for the production of drugs; gene therapeutics; medicinal products of the special therapeutic approaches.
III.
Pharmaceutical Technology/biopharmaceutical development, production, properties, testing and biopharmaceutical evaluation of drug forms; modern drug delivery systems; tissue and organ-specific forms of administration, special features of medicinal products with bio-and Genetically engineered medicinal products and of cytostatic preparations; Building principle, composition, handling and use properties of ready-to-use products; special dosing systems; requirements of pharmacopoeias for pharmaceutical preparations; Medicinal products of the homeopathic pharmacopoeia; properties, testing and assessment of the basic and adjuvant substances necessary for the manufacture of medicinal products, as well as common active substances and packaging; pharmaceutical-technological basic operations, Process engineering, machinery, control technology; biopharmaceuticals, application routes and resorption sites, pharmacokinetic bases for the development and testing of medicinal products, bioavailability, bioequivalence testing and assessment, in-vitro/in-vivo correlation; quality assurance in the manufacture and testing of medicinal products, including statistical methods; legal bases of quality assurance, validation, inprocess and final controls; stability and stabilisation of medicinal products; Incompatibilities and interactions; blood substitutes and blood and preparations thereof, sera and vaccines; medical devices placed on the market in pharmacies.
IV.
Pharmacology and toxicology macroscopic, microscopic, pathobiochemical as well as functional changes in organs and organ systems in major diseases; epidemiology, Development, symptoms, progression, prognosis and prevention of major diseases, including those that are accessible to self-medication; assessment of clinical-chemical measurement results; nutritional measures in the case of important diseases Diseases; effects of medicinal products, mechanism of action, metabolism, pharmacokinetics, side effects, interactions, contraindications and dosage, hazards due to improper use; general pharmacotherapy of important diseases including those accessible to the self-medication; toxicology of the excipients and pollutants; methods for the determination of pharmacological and toxicological effects; clinical trial; biometric methods.
V.
Clinical Pharmacotherapy Special pharmacotherapy; Special features of drug therapy in pregnancy and breast-feeding, pediatrics, geriatrics, in patients with limited Organ function, multimorbidity; importance of pharmaceutical form and route for therapy; dialysis procedures; special features of certain regimens, especially for anti-infective therapy, oncological therapy and support therapy, which anti-coagulant therapy, immune and gene therapy; therapy of intensive care patients; criteria for drug evaluation; pharmaceutical anamnes; benefit-risk assessment of a drug therapy; assessment of the clinical relevance of adverse effects, Interactions and incompatibilities, assessment of combination therapies; cause of variability in the success of drug therapy; therapeutic recommendations based on specific patient cases; Therapeutic drug monitoring, handling of patient records; Medicinal products for the application of medicinal products and for enteral and parenteral nutrition; compliance/non-Compliance; principles and methods of pharmacovigilance; relationship between pharmacodynamics and pharmacokinetics; Population pharmacokinetics; clinical pharmacogenetics; malnutrition, energy and nutritional needs; enteral and parenteral nutrition; health economics, pharmacoepidemiology and economics, pharmacovigilance, methods of determining the Quality of life, ethical aspects.
unofficial table of contents

Appendix 15 (to § 19 para. 3)
Third Section Examination Pharmacist examination

Fundstelle des Originaltextes: BGBl. I 2000, 1724
Pharmaceutical basic principles of formulation and defect; incompatibilities; basic principles of the development, production and approval of ready-to-use drugs; Conformity assessment of medical devices; possibilities for influencing the durability of medicinal products; procurement, documentation, evaluation, evaluation and dissemination of information on medicinal products and medical devices; information and advice of patients, physicians and other healthcare professionals on medicinal products and medical devices placed on the market in pharmacies, in particular on proper storage and use, side-effects and interactions; hazards of Persistent smoking and abuse of medicines; aspects of quality assurance; applied pharmacotherapy; drug counselling and selection in self-medication; interpretation of medical, dental and veterinary prescriptions; and their terminology; practical aspects of pharmaceutical support; pharmacological services; blood and blood products; hospital hygiene; economic aspects of the use of medicinal products and medical devices; products for infants and children; and Nutrition and nutrition for diseases; food supplements; products for enteral and parenteral nutrition; products and articles for body care, plant protection and nutrition. Pest control; health promotion; accident prevention, occupational health and safety and measures of first aid; business fundamentals of pharmacy operations, in particular accounting, annual accounts, profitability, rationalisation, Control.
II.
Special jurisdication areas for a pharmacy overview on the delimitation of the following areas of law: state law, administrative law, criminal law, civil law, Trade law; distinction between law, decree law, administrative provision, statutes; professional law for pharmacists; training and duties of the other professions in pharmacies, legal bases; chamber laws including Professional jurisdiction; pharmacy law, in particular law on pharmacy and pharmacy regulations; other provisions important for pharmacy operations from other jurisditions; broad lines of the history of pharmacy; pharmaceutical products and the right to narcotics, in particular the Medicines Act, the Remedies Act and the Narcotics Act, as well as decree-law regulations; medical product law; particularities of the national and international pharmaceutical market; , in particular, advertising, advertising and pricing; regulations on the handling and transport of hazardous substances; tasks and organisation of health administration at federal, state and local level; and on the international level; legal basis for the Economic aspects of pharmacy management, social security law.
unofficial table of contents

Appendix 16 (to § 21 sentence) 1)
Approbationsurkunde

(site of the original text: BGBl. I 1989, 1508)
Mr./wife ........................, born on ........................
in ........................................., is due to § 4 of the
federal pharmacist order with effect from today's day

the Approbation
granted as a pharmacist/pharmacist
.

...................., the ............
seal
.....................................
(signature)
unofficial table of contents

appendix 17 (to § 22a (7))
permission in accordance with § 11 (1) or (1a) of the federal pharmacist order

/wife. ................................................................................................................................................................................. .
(first name, surname-possibly deviating birth name)
born on. ........................................... .in. ...................................................................... .
In accordance with Section 11 (1/1a) of the Federal Pharmacists ' Order, permission is granted for the temporary Exercise of the
pharmacy profession in/on. ................................................................................................................................................................... .
for the time from. ......................................................................... .to. ............................................................ Revocable.
Restrictions and minor provisions:
.. .................................................................................................................................................................. .
.. .................................................................................................................................................................. .
.. .................................................................................................................................................................. .
The permission also includes the activity in the country. .......... /in the countries. .......... /nationwide
activity * as. ........................................... .
Siegel



. ........................................... , the. ........................................... .
.. .............................................................................................. .
(Signature)
*
Delete as applicable.
unofficial table of contents

Appendix 18 (to § 22c paragraph 6)
Niederschrift über die sovereign suitability test according to § 22c of the Approbationsordnung für Apotheker

Mr./Woman. ................................................................................................................................................................................. .
born on. ........................................... .in. ................................................... .
is on. ................................................. .in. ....................................... checked.
Start and end of the individual/group check:. ............................................................................................................. .
He/She has the state aptitude test passed/did not pass.
Traying reasons:. ................................................................................................................................................. .
.. ........................................................................................................................................................................ .
Members of the Examination Committee according to § 22c (4) of the Approbationsordnung für Apotheker:
As chairman (r). ........................................... .
As additional members
. . .......................................... .
.. .......................................... .
.. .......................................... .
.. .......................................... .
The subject of the review:. .................................................................................................................................... .
.. .................................................................................................................................................................. .
(Content and validation flow are to be reproduced)
Other remarks:. ..................................................................................................................................... .
.. .................................................................................................................................................................. .
.. .................................................... , the.. .......................................... .
.. ......................................................... ... .......................................... .
.. ......................................................... .
.. ......................................................... .
.. ......................................................... .
(subscript/s of the other member
of the other members of the Examination Committee)
(Signature of the Chairman of the Examination Committee
Table of contents

Appendix 19 (to § 22d (6))
Niederschrift über die STATE Profinisprüfung nach § 22d der Approbationsordnung für Apotheker

Mr./wife. ................................................................................................................................................................................. .
born on. ........................................... .in. ................................................... .
is on. ................................................. .in. ....................................... checked.
Start and end of the individual/group check:. ............................................................................................................. .
He/She has the state aptitude test passed/did not pass.
Traying reasons:. ................................................................................................................................................. .
.. ........................................................................................................................................................................ .
Members of the Examination Committee according to § 22d (3) of the Approbationsordnung für Apotheker:
As chairman (r). ........................................... .
As additional members
. . .......................................... .
.. .......................................... .
.. .......................................... .
.. .......................................... .
The subject of the review:. .................................................................................................................................... .
.. .................................................................................................................................................................. .
(Content and validation flow are to be reproduced)
Other remarks:. ..................................................................................................................................... .
.. .................................................................................................................................................................. .
.. .................................................... , the.. .......................................... .
.. ......................................................... ... .......................................... .
.. ......................................................... .
.. ......................................................... .
.. ......................................................... .
(subscript/s of the other member
of the other members of the Audit Commission)
(signature of the chair of the examination board